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Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules (TRAF)

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ClinicalTrials.gov Identifier: NCT03646383
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE March 25, 2018
First Posted Date  ICMJE August 24, 2018
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE January 29, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
Procedure response rate [ Time Frame: 6 months ]
First estimate of the procedure response rate (patient with complete procedure in percentage)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03646383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Change in nodular volume [ Time Frame: at 6 and 12 months ]
    compared to the volume measured at inclusion. This reduction will be estimated in absolute value and in relative value (percentage reduction for a given subject)
  • volume change of nodules by at least 50 percent, at 6 months [ Time Frame: at 6 months ]
    Percentage of patients with a volume decrease of at least 50 percent, 6 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent
  • volume change of nodules by at least 50 percent, at 12 months [ Time Frame: at 12 months ]
    Percentage of patients with a volume decrease of at least 50 percent, 12 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent
  • complete disappearance of symptoms [ Time Frame: at 12 months ]
    The symptoms will be evaluated by a visual analogue scale of 0 to 10 as proposed by the Korean consensus. The symptoms assessed will be: cervical pain, dysphagia, foreign body sensation, discomfort, coughing.
  • aesthetic change [ Time Frame: at 3, 6 and 12 months ]
    This improvement will be evaluated with a 4-level scale (no clinically detectable nodule 0, palpable nodule 1, visible nodule on swallowing 2, spontaneously visible nodule 3) as proposed by the Korean consensus. The improvement will be defined by the transition to the lower category.
  • one or more complications [ Time Frame: at 6 and 12 months ]
    In particular, the following will be investigated: signs of cutaneous involvement such as burns, hematoma and intra-nodular bleeding, recurrent paralysis, superinfections, tracheal or esophageal wounds.
  • Assessment of pain during the procedure with visual analogue scale [ Time Frame: between Day 1 and Day 15 ]
    Evaluation of the pain during the procedure using a visual analogue scale from 0 to 10 established at the end of the procedure
  • patients requiring L-thyroxine replacement therapy [ Time Frame: at 6 and 12 months ]
    Percentage of patients requiring L-thyroxine replacement therapy
  • Economic evaluation from the point of view of the hospital [ Time Frame: Between Day 1 and 12 months ]
    evaluation, from the point of view of the hospital, of the production cost of the new technique
  • patients who have used analgesics [ Time Frame: between Day 1 and Day 15 ]
    Percentage of patients who have used analgesics during and after the procedure
  • Economic evaluation from the point of view of the health insurance [ Time Frame: Between Day 1 and 12 months ]
    Evaluation, from the point of view of health insurance, of the cost of the care of patients who benefited from the new technique
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
  • Difference in nodular volume [ Time Frame: at 6 and 12 months ]
    compared to the volume measured at inclusion. This reduction will be estimated in absolute value and in relative value (percentage reduction for a given subject)
  • Percentage of patients with a volume decrease of nodules by at least 50 percent, at 6 months [ Time Frame: at 6 months ]
    Percentage of patients with a volume decrease of at least 50 percent, 6 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent
  • Percentage of patients with a volume decrease of nodules by at least 50 percent, at 12 months [ Time Frame: at 12 months ]
    Percentage of patients with a volume decrease of at least 50 percent, 12 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent
  • Percentage of patients with complete disappearance of symptoms [ Time Frame: at 12 months ]
    The symptoms will be evaluated by a visual analogue scale of 0 to 10 as proposed by the Korean consensus. The symptoms assessed will be: cervical pain, dysphagia, foreign body sensation, discomfort, coughing.
  • Percentage of patients with aesthetic improvement [ Time Frame: at 3, 6 and 12 months ]
    This improvement will be evaluated with a 4-level scale (no clinically detectable nodule 0, palpable nodule 1, visible nodule on swallowing 2, spontaneously visible nodule 3) as proposed by the Korean consensus. The improvement will be defined by the transition to the lower category.
  • Percentage of patients with one or more complications [ Time Frame: at 6 and 12 months ]
    In particular, the following will be investigated: signs of cutaneous involvement such as burns, hematoma and intra-nodular bleeding, recurrent paralysis, superinfections, tracheal or esophageal wounds.
  • Assessment of pain during the procedure with visual analogue scale [ Time Frame: between Day 1 and Day 15 ]
    Evaluation of the pain during the procedure using a visual analogue scale from 0 to 10 established at the end of the procedure
  • Percentage of patients requiring L-thyroxine replacement therapy [ Time Frame: at 6 and 12 months ]
    Percentage of patients requiring L-thyroxine replacement therapy
  • Economic evaluation from the point of view of the hospital [ Time Frame: Between Day 1 and 12 months ]
    evaluation, from the point of view of the hospital, of the production cost of the new technique
  • Percentage of patients who have used analgesics [ Time Frame: between Day 1 and Day 15 ]
    Percentage of patients who have used analgesics during and after the procedure
  • Economic evaluation from the point of view of the health insurance [ Time Frame: Between Day 1 and 12 months ]
    Evaluation, from the point of view of health insurance, of the cost of the care of patients who benefited from the new technique
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules
Official Title  ICMJE Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules by Percutaneous Radiological Approach
Brief Summary

The purpose of the present protocol is to evaluate the response rate to treatment of these symptomatic benign nodules with radiofrequency as an alternative to surgical treatment.

This thyroid nodules ablation with radiofrequency will be directed by a single percutaneous procedure guided by ultrasound. The procedure includes an ultrasound with percutaneously radiofrequency ablation of benign thyroid nodule. Clinical and ultrasonographic monitoring will last a year with consultations at 2 weeks (consultation only), 3 months, 6 months and 1 year (consultation, ultrasound TSH). The success of this procedure will be controlled with 3 successive ultrasounds the following year. The expected results are a decrease in the size of the nodule by at least 50% and a reduction in the functional and aesthetic discomfort, with less frequent complication than what is expected with surgery. The present study also intends to determine the medico economic impact of this technique compared to surgery.

Detailed Description Thyroid benign nodules represent a major public health problem because they are very common (subclinical nodules were found in half of woman beyond 60 years). The main risk factors include age, female gender, parity, smoking and family history of thyroid nodules or thyroiditis. The assessment is based on biology, ultrasound and fine needle aspiration and intends to determine the benign nature (95%) or cancer (5%) of the nodules and if they are functional or not (toxic nodule). Most benign nodules are asymptomatic but some of them because of their size and location can cause a functional disorder (compression or swallowing disorder) or aesthetic and psychological resounding.In current practice, these nodules are sometimes treated with surgery that impact on patient quality of life (need to take L-Thyroxine, difficulties related to the possible occurrence of complications like hypoparathyroidism or laryngeal paralysis) and socio-economic constraints especially when complications occur. To limit the number of unnecessary and potentially risky surgeries, patients should therefore be well selected. If surgery is the preferred treatment of thyroid cancer, alternative techniques like radiofrequency seem interesting for benign nodules.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Benign Thyroid Nodules
Intervention  ICMJE Procedure: Radiofrequency ablation
The procedure will include an ultrasound with radiofrequency ablation of the benign thyroid nodule percutaneously
Study Arms  ICMJE Experimental: Treatment with radiofrequency
Treatment of symptomatic benign nodules with radiofrequency ablation as an alternative to surgical treatment
Intervention: Procedure: Radiofrequency ablation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Euthyroid or hypothyroidism properly substituted with normal TSH
  • Benin nodule proved by FNA (Bethesda) and normal Calcitonin
  • Nodule size> 1cm and / or increase in size
  • Single nodule or asymptomatic nodules associated
  • Symptomatic nodule with functional impairment and / or aesthetic Patient Agreement
  • Patient with insurance coverage
  • Written agreement for participation

Exclusion Criteria:

The exclusion criteria are related to the histological nature of the nodule and the necessary of the procedure:

  • Allergy to local anesthetics
  • FNA non-contributory or suspicious nodule (Bethesda)
  • Multiple nodules more than 2cm
  • Hyperthyroidism or hyperparathyroidism associated requiring surgical intervention.
  • Taking a treatment with anticoagulant or double antiplatelet
  • Patient with a Pacemaker
  • Contralateral laryngeal paralysis in nodule
  • Purely cystic nodule
  • Nodule in contact with the recurrent nerve
  • Patient Refusal
  • Pregnant and breastfeeding women
  • Patient trust, guardianship or safeguard justice.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Claire RENAUD, MD 5 67 77 17 78 ext 33 renaud.c@chu-toulouse.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03646383
Other Study ID Numbers  ICMJE RC31/17/0352
2018-A00669-46 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claire RENAUD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP